Silimed Pectoral Implant
FDA 510(k) K042054 · Silimed, Inc.
510(k) numberK042054
Submission
- Device name
- Silimed Pectoral Implant
- Applicant
- Silimed, Inc.
Crofton, MD, US - Received
- July 30, 2004
- Decision date
- February 23, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MIB – Elastomer, Silicone Block
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.3620
- Specialty
- Ear, Nose, Throat
- Implant
- Yes
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| K223051 | Pre-Formed Silicone BlockMIB · Traditional | International Medical Devices, Inc. | 02/03/2023SE |
| K222748 | ShiNeo Silicone ImplantMIB · Traditional | Shineo Technology Co., Ltd. | 12/23/2022SE |
| K200073 | AugMENTA Penile ImplantMIB · Traditional | Augmenta, LLC | 09/30/2022SE |
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| K193392 | BioSiCar Silicone ImplantMIB · Traditional | Metalware Technology Corp. | 07/20/2020SE |
| K181387 | Pre-Formed Penile Silicone BlockMIB · Traditional | International Medical Devices, Inc. | 01/23/2019SE |
| K171851 | SoftxilMIB · Traditional | Bistool | 03/16/2018SE |
| K162624 | Pre-Formed Penile Silicone BlockMIB · Traditional | International Medical Devices, Inc. | 02/01/2017SE |
| K052505 | Calf Implant, Model EC17-XMIB · Traditional | Implantech Associates, Inc. | 11/04/2005SE |
More from Implantech Associates, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K981852 | Silimed Tissue ExpanderLCJ · Traditional | 08/05/1998SE |
| K974479 | Silimed Vaginal StentKXP · Traditional | 08/05/1998SE |
| K981851 | Silimed Silicone Carving BlockMIB · Traditional | 07/09/1998SE |
| K981850 | Silimed Chin ImplantsFWP · Traditional | 07/09/1998SE |
| K981835 | Silimed Malar ImplantLZK · Traditional | 07/09/1998SE |
| K981833 | Silimed Nasal L Shaped ImplantFZE · Traditional | 06/26/1998SE |
| K980221 | Silimed Nasal RetainerLYA · Traditional | 04/02/1998SE |
| K974482 | Silimed Gluteal ImplantMIB · Traditional | 02/24/1998SE |
| K974480 | Silimed Calf ImplantMIB · Traditional | 02/24/1998SE |
Questions and answers
When was Silimed Pectoral Implant cleared by the FDA?
Silimed Pectoral Implant (K042054) received a 510(k) decision of Substantially Equivalent on February 23, 2005, 208 days after the submission was received.
What is the product code of K042054?
The FDA product code is MIB – Elastomer, Silicone Block, a Class II (moderate risk) device regulated under 21 CFR 874.3620.